The goal of this research is investigating the music's effects on the pain of heel blood sampling on infants of a hospital in Saveh city.
The study's population is the infants who refer to 17-shahrivar hospital of Saveh city to perform thyroid screening test. Some inclusion criteria are as follows:,Gestational age is 37 to 42 weeks, Birth weight is 2500-4000 gr, The infants have not been received Naloxone during the last 24 hours. The infants have not been received sedative, tranquilizers or anticonvulsants within 12 hours before blood sampling and The infants are awake, quiet and without crying. Some exclusion criteria are as follows: If blood tests for thyroid disorder confirms hearing loss in infants and If the related tests diagnoses thyroid disorders.
Infants will be selected by convenient sampling. Samples are randomly divided into three groups: Intervention group (1) tested by heart sound (60 persons), intervention group (2) tested by the song Lullaby (60 persons) and control group (60 persons). The mentioned procedure continues until the sample is completed. The researchers use headphones and MP3 player to prevent from bias in all three groups.
First, for each infant is completed a questionnaire of demographic' information. Next, for intervention group (1) and (2) the music is played using a MP3 player and headphones from one minute before and during heel blood sampling, while for control group will not be played any music. The pain intensity is evaluated by researcher for each of the three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201098651N1
Registration date:2012-09-26, 1391/07/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-26, 1391/07/05
Registrant information
Name
Nasrin Safari
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 5234 3395
Email address
dr.safari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences approved research project
Expected recruitment start date
2011-10-22, 1390/07/30
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of music on pain of heellance blood sampling in neonates
Public title
Effect of music on pain in infants
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria:Gestational age is 37 to 42 weeks؛Birth weight is 2500-4000 gr؛The infants have not been received Naloxone during the last 24 hours؛The infants have not been received sedative, tranquilizers or anticonvulsants within 12 hours before blood sampling؛ The infants have not been had any problem such as heart, respiratory, nervous or chromosomal abnormalities؛ The infants are awake, quiet and without crying؛ The age of infants' mothers is between 18 and 35 years.
The exclusion criteria:If blood tests for thyroid disorder confirms hearing loss in infants؛If the related tests diagnoses thyroid disorders.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
School of Medical Sciences Saveh, Yas Avenue, Kaveh Industrial City, Saveh,Iran
City
Saveh
Postal code
Approval date
2011-09-05, 1390/06/14
Ethics committee reference number
8-112-90
Health conditions studied
1
Description of health condition studied
Heel pain during blood sampling
ICD-10 code
M79.6
ICD-10 code description
Pain in limb
Primary outcomes
1
Description
naonats pain
Timepoint
during intervention
Method of measurement
Using standard tools of infant pain assessment tools (DAN) (Douleur Aiguë Nouveau-né
Secondary outcomes
empty
Intervention groups
1
Description
Control group: no music, do not receive
Category
Other
2
Description
Intervention group I:For this group, one minute before blood sampling and the whole time of the blood sampling, heart beat sound is played with headphones
Category
Other
3
Description
Intervention group II:For this group, one minute before blood sampling and the whole time of the blood sampling lullaby music is played with headphones
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Hospital
Full name of responsible person
Nasrin Safari
Street address
School of Medical Sciences Saveh, Yas Avenue, Kaveh Industrial City, Saveh,Iran
City
Saveh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nasrin Safari
Street address
School of Medical Sciences Saveh, Yas Avenue, Kaveh Industrial City, Saveh,Iran
City
Saveh
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences.School o Medical Sciences Saveh
Full name of responsible person
Nasrin Safari
Position
MS in Nursing. Instructor
Other areas of specialty/work
Street address
School of Medical Sciences Saveh, Yas Avenue, Kaveh Industrial City, Saveh,Iran
City
Saveh
Postal code
Phone
+98 25 5234 3395
Fax
Email
dr.safari@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences, School of Medical Sciences Saveh
Full name of responsible person
Nasrin Safari
Position
MS in Nursing
Other areas of specialty/work
Street address
School of Medical Sciences Saveh, Yas Avenue, Kaveh Industrial City, Saveh,Iran
City
Saveh
Postal code
Phone
+98 25 5234 3395
Fax
Email
dr.safari312@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences. School of Medical Sciences Saveh
Full name of responsible person
Nasrin Safari
Position
MS in Nursing. Instructor
Other areas of specialty/work
Street address
School of Medical Sciences Saveh, Yas Avenue, Kaveh Industrial City, Saveh,Iran
City
Saveh
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)